Expanded access for nonconforming afami-cel (Tecelra)
Part of Cancer clinical trials.
This trial lets people who were already prescribed Tecelra get their treatment even if their manufactured dose did not meet standard quality checks. It is for people with no other options for re-making the dose or collecting cells again.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You have been prescribed Tecelra for your condition.
- Your made dose did not pass the standard quality checks.
- Making a new dose or collecting your cells again is not possible or safe for you.
- Your doctor thinks treatment with this dose is safe and in your best interest.
- You are healthy enough to receive the treatment, and if you could become pregnant, you have a negative pregnancy test before starting.
- You do not have a specific genetic marker (HLA-A*02:05P) that makes Tecelra unsafe.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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